Approved

Ganirelix: Uses, Mechanism, and Side Effects

Molecular formulaC80H113ClN18O13
Molecular weight1570.3 g/mol
Registered trials109
PubChem CID16130957
Brand namesGanirelix Acetate

Women undergoing fertility treatment need precise timing to keep an IVF cycle on track. Ganirelix is a medication used specifically to prevent an untimely hormonal surge that could disrupt that timing.

Key takeaways

  • Ganirelix Acetate Injection is approved to inhibit premature LH surges during controlled ovarian hyperstimulation.
  • It carries no boxed warning on its label.
  • More than 100 clinical trials have registered activity involving ganirelix.
  • Ovarian hyperstimulation syndrome is the most frequently reported adverse event in post-marketing reports.
  • The compound is identified in PubChem under CID 16130957.

What Ganirelix Is

Ganirelix is a synthetic peptide used in assisted reproduction protocols. It is marketed under the brand name Ganirelix Acetate. The label does not detail a specific pharmacologic class or mechanism statement beyond its indicated use.

What Ganirelix Is Approved For

Ganirelix Acetate Injection is indicated for women undergoing controlled ovarian hyperstimulation, where it is used to inhibit premature LH surges. Preventing this surge helps keep the timing of egg retrieval aligned with the treatment protocol. No boxed warning is present on the label.

What the Evidence Shows

Ganirelix has been studied across 109 registered clinical trials. One completed Phase 2/3 trial examined endometrial injury and IVF outcome parameters in patients with prior failed IVF cycles. A separate completed Phase 3 trial evaluated initiating ovarian stimulation with recombinant human FSH during the late follicular phase, a context in which ganirelix is used to manage the treatment cycle.

Reported Side Effects

FAERS data reflect adverse event reports, not confirmed incidence or causation. The most frequently reported reaction is ovarian hyperstimulation syndrome (253 reports), followed by ascites (58) and pleural effusion (22), reflecting the fertility-treatment context in which ganirelix is used. Other reported reactions include nausea (37), dyspnoea (34), abdominal pain (28), and headache (26), along with reports of drug ineffectiveness (27).

FAQ

What is ganirelix used for?
Ganirelix Acetate Injection is approved to inhibit premature LH surges in women undergoing controlled ovarian hyperstimulation. This helps keep fertility treatment cycles, such as IVF, on their intended schedule.
Does ganirelix have a boxed warning?
No, the current label for Ganirelix Acetate Injection does not carry a boxed warning.
What is the most commonly reported side effect of ganirelix?
Ovarian hyperstimulation syndrome is the most frequently reported reaction, with 253 reports in the FAERS data reviewed. Ascites and pleural effusion were also reported, though these figures reflect reported cases rather than confirmed incidence.
How much clinical research exists on ganirelix?
Ganirelix has been involved in 109 registered clinical trials. These include studies on IVF outcomes and protocols combining ganirelix with ovarian stimulation medications.
What brand name is ganirelix sold under?
Ganirelix is marketed under the brand name Ganirelix Acetate.
This page is an editorial information resource. It does not sell, prescribe, or recommend any medication. Content is editorial information, not medical advice. Talk to your doctor before any treatment decision.

Sources: FDA label (DailyMed) ClinicalTrials.gov FDA FAERS PubChem

Updated 2026-09-19